CN103442762A

CN103442762A - Laryngeal mask and tracheal tube airway device

Info

Publication number: CN103442762A
Application number: CN2012800147132A
Authority: CN
Inventors: D·M·米勒
Original assignee: Individual
Current assignee: Individual
Priority date: 2011-03-23
Filing date: 2012-03-22
Publication date: 2013-12-11
Also published as: US20140000624A1; WO2012127436A2; GB2489407A; GB201104865D0; WO2012127436A3; WO2012127436A9

Abstract

An airway device (10) is provided which includes a distal part (12) and a proximal part (20) in sealed communication. The distal part (12) has a distal opening (14) for attachment to a breathing apparatus, in sealed communication with a hollow stem (16). The proximal part comprises a hollow sealing chamber (20) with a proximal opening (22), said sealing chamber (20) having means for sealing within and against the mucosal walls of a body cavity with a corresponding proximal opening, for communicating with the lungs. The sealing means of the sealing chamber (20) includes: a longitudinal fold (32) that allows for adaptation to varying cross-sectional dimensions of said body cavity; and said sealing chamber (20) being made of an elastomeric substance and having walls (26,30) that are thicker and relatively less flexible, and walls (24,25) that are thinner and relatively more flexible, said thicker walls (26,30) forming a framework that supports said thinner walls (24,25).

Description

Laryngeal mask and endotracheal tube airway device

Technical field

The present invention relates to breathing apparatus, the form of this breathing apparatus is the pars oralis pharyngis (oro-pharynx) of inserting unconscious patient or the artificial airway apparatus of trachea.

Background technology

In order to support, breathe and life, unconscious patient may need some or all following purpose, that is: maintenance air passage unobstructed, be connected with respiratory organ, spontaneous or controlled positive airway pressure, for example prevent, in external foreign body (, vomitus or blood) suction lung.

In long-term oxygen supply process when Intensive Care Therapy, the liquid of revealing from the seal arm band of endotracheal tube can cause problem and the sealing trachea arm band pressure of the nosocomial infection (nosocomial infection) of pulmonary to damage the potential problems that cause (pressure damage) (comprising mucosa injury and recurrent nerve injury).The damage of the pressure of the seal arm band of glottis airway can also cause the mucosa wound, and more serious for example, nerve injury on the nerve (, recurrent laryngeal nerve and nervus sublingualis) that affects language.In addition, may need the endotracheal tube blindmate is entered in trachea and by the stomach tube blindmate to enter in esophagus.

Term used herein " closely " (contiguous patient) and " far " (away from patient) are usingd the patient as reference.

In anesthesia or resuscitation process, can realize airway management by endotracheal tube, described endotracheal tube has inflatable arm band, and this arm band, around the near-end of this endotracheal tube, is inserted described inflatable arm band under the help of endotracheal other instruments.Shortcoming is, need to accurately insert, and this accurately inserts the skilled worker who needs special training, and endotracheal tube is inserted to relative aseptic area needs more invasives, and also may need laryngoscope while inserting.Insert described endotracheal tube and usually need to use the muscular paralysis medicine.In order to remove possible fluid composition, can utilize during endotracheal tube fixedly inserts stomach by buccal cavity route or nasal cavity route by stomach tube after airway.Once be provided with endotracheal tube, described arm band pressure may rise too much, causes mucosa injury-or rarely even cause nerve or the teleneuron of below are caused to damage.

Inflatable arm band itself in endotracheal tube can cause at the recurrent laryngeal nerve place of very pressing close to described trachea the pressure damage.More commonly, the pharyngeal secretions that carries disease germs come off can permeate the burst through the arm band of the described endotracheal tube with arm band downwards, produces intrapulmonary infection.

By using the laryngeal mask airway (LMA of a type ^tM) can address these problems.This may relate to the use of inflatable arm band, and this arm band is around the bowl-type end of conduit, with the inlet seal by throat.The invasive of described laryngeal mask airway is less than the invasive of above-mentioned endotracheal tube, and described laryngeal mask airway does not need to relax one's muscles.Yet the backflow of liquid vomitus or blood can enter in the bowl of LMA easily, and causes pulmonary aspiration.In addition, throat packing (perilaryngeal seal) quality is not very high, and may limit operable the blowing pressure.When using higher the blowing pressure, air can be forced into to esophagus, and enter in stomach-produce flatulence or gastric liquid return.

Found the improvement to above-mentioned two limiting factors in the further slightly complicated improvement of glottis airway device.Be called " Combitube

" esophageal atresia air flue (EOA) or derivant (attraction type larynx conduit) or the improved form that is called the laryngeal mask of ProSeal LMA be provided with drainage tube, this drainage tube allows to enter Endo-esophageal air and liquid is overflowed from esophagus.The device that comprises drainage tube allows the path of the needed mouth-stomach tube of possibility in some surgical operations to enter in stomach usually.

Combitube and attraction type larynx conduit comprise two-chamber both arms band pipe (double lumen double cuffed tube), the longer pipe with fixing arm band through esophagus with sealing with separate and may enter the material of described esophagus from below or prevent that the gas of top from overflowing and entering gastric under the effect of pressure.Shorter pipe is for ventilating to pharyngeal interior lung end, and pharyngeal mouth and nose outlet is by the second arm band and pharyngeal inner sealing, and described the second arm band is around two pipes, and when inflation, described the second arm band permission is in pharyngeal interior generation malleation.

Mark Lorraine medical company (Mallinckrodt Medical, Inc) has been introduced a kind of arm band oropharyngeal airway (COPA

) (US5,743,256) also have the Cobra airway, this arm band oropharyngeal airway can be for obtaining some above-mentioned purposes, but can not prevent from entering pharyngeal foreign body enters in lung.This arm band oropharyngeal airway stops production.The aperture of glottis sealing airway (WO98/16273) of Augustine's medical company (Augustine Medical Inc) is intended to realize this advantage, yet described glottis sealing airway is not as initial wish reliable like that.Occur multiple other both arms band aerating device on current market, and can be classified as above-mentioned EOA and COPA derivant (for example, Sato(US 5,743,258)) and other.

Sealing described pharyngeal up-to-date glottis airway is those airways of glottis without any inflatable arm band, and these glottis airways comprise SLIPA ^tMairway, i-gel airway (WO 2004/016308) and Pascal airway device (Baska Airway device) (US 2006/0180156).Described SLIPA airway is that the present inventor is designed, is first in these devices, and comprises the plastic chamber of the anatomic shape of hollow, and this plastic chamber shape meets described pharyngeal.Described chamber has the hole corresponding with patient's throat (orifice).Described chamber is used as the fluid acquisition part (trap) from any source, and therefore has the effect that lung sucks protection.The same with the Cobra airway with Combitube, trunnion, COPA, described SLIPA airway device is at the sealed bottom of tongue.The sealing mechanism of described SLIPA airway device is for dissecting the preformation die cavity, and the shape of this preformation die cavity meets pharynx.Described sealing depends on the elastic force of bowl-shape moulding material, and the adequate rigidity of this elastic force is to keep against described pharyngeal wall, and this is also supported (Anesthesia and analgesia 2004, the 99 volumes) by the airway pressure on the inwall in described chamber.

Should be noted that, the prototype silicon offset plate of the SLIPA airway of nineteen ninety-five is made by the silica gel material of thin-walled, wherein the thin-walled by described device is firmly held on mucosal wall by described airway pressure, and institute is so that described airway pressure has kept high-quality self-excitation sealing (self-energizing seal).This device did not put into production or the public can not obtain at that time.

I-gel is and ring larynx sealing device (peri-laryngeal sealing device) like the LMA category, but i-gel uses is that the very flexible soft solid arm band material low by Shore hardness realized pharyngeal sealing but not mattress.The air-breathing protection mechanism herein adopted is similar to the suction tube used in the ProSeal laryngeal mask airway device.

The maximum that is subject to preventing the wedging force of solid arm band of tissue injury or described arm band in the blowing pressure maximum before solid or gas inflated arm band generation Leakage Gas can allow the restriction of the blowing pressure.Due to a large amount of sealed arm bands of volume be filled with air or the solid soft material occupies, while occurring to reflux, be the material that refluxes or the limited storage space of other secretions or blood.Laryngeal mask and i-gel provide part sealing and the isolation between esophagus and airway pressure, and may reflux.Yet liquid can penetrate weak airway seal member, and reflux materials can enter in described " bowl ", should " bowl " comprises the part of described airway passage.If above-mentioned situation occurs, the limited storage capacity because the sealing mechanism of large volume causes even a small amount of liquid/material enters in described bowl, all likely enters in lung in air-breathing process.

The Cobra airway of COPA and renewal does not arrange any esophagus sealing, and has reported air-breathing generation.Reported that in the device with drainage tube, generation is air-breathing.

Combitube and derivant thereof (for example, trunnion series) sealing esophagus, and as if to controlling ventilation effectively, but the correct layout of described Combitube can throw into question-or too dark, or dark not.In addition, it is very meticulous operation that described Combitube correctly is set, and very expensive.

In order to overcome the air-breathing risks and assumptions relevant to LMA, be known as " ProSeal " LMA(and, recent property version, LMA " Supreme ") food meatus that improved LMA comprises intermediate pore size, this food meatus is for removing the liquid (JP 2-283378) that may accumulate in the face shield district (mask region) of described airway because of suction or siphonage.

More in the recent period, Baska face shield airway is used a kind of device, this device is by restriction and the suction of the design improvement backflow risk of laryngeal mask, this laryngeal mask front end has chamber or groove (sump), this chamber or groove are for collecting withdrawing fluid and fast and effeciently removing-mono-for suction by two conduits, and another is for introducing air the groove of collecting fluid.This more effectively remove on one's own initiative withdrawing fluid can be more effective than the device with simple stomach tube.Described Baska airway (WO 2009/026628) comprises corrugated tube action (bellows action), self-excitation sealing mechanism.

It is the effective means achieved the above object that endotracheal tube is arranged in trachea, yet, use described endotracheal tube to need experience, technology and utilize laryngoscope or the glottis airway of particular design (for example, intubatton type laryngeal mask (Fastrach)), therefore cause undesired side effect, this side effect to cause very strong neural reflex effect.Endotracheal tube is set and also may needs to utilize the muscular paralysis medicine.

Said apparatus is made by soft flexible material, and the said equipment must removably be fixedly connected with respirator by bindiny mechanism, and described bindiny mechanism has enough toughness, to prevent unexpected disengagement.Respirator and airway device are separated to required power and should surpass 30 newton.In order to reach this purpose, the protrusion adapter that usually needs duroplasts to make, this protrusion adapter (by barb accessory or cementing or utilize good frictional fit to stretch) is for the softer material of airway device.Some potential hazards can be thrown off and cause to above-mentioned connection once in a while, if possible preferably avoids.In addition, the material (extra mould) cost and the labor cost that have also related to ancillary cost during manufacture.If the part of the airway device connected with breathing apparatus by the remainder with described airway device identical softer material make, can reach many functions and manufacture advantage.

The nearest improvement that the present inventor makes relates to and is known as SLIPA ^tMthe packer of (as mentioned above) (WO 02/32490) and the combination of airway device.This device solves above-mentioned much for described device for supporting unconscious patient's purposes, but different from all existing apparatus, described device has been used the standard 15mm fixed connector of BS 5356 standards that meet tapered coupling.These fixed connectors are made by the material that is different from described airway device, caused frictional grip between described fixed connector and described airway device not enough sometimes, and potential risk can be thrown off-have to described airway device and described fixed connector therefore potentially.In addition, these adapters have limited the diameter that can pass the instrument of this adapter.For many years, utilize larger instrument (for example, standard-sized endotracheal tube passes through) to become the target (desirable objective) of an expectation.

Be specifically designed to the AirQ laryngeal mask airway be improved to by Daniel Cook doctor design that larger conduit passes through, this AirQ laryngeal mask airway is designed to have the adapter of 15mm, this adapter can easily be removed and reconnect, and to allow larger endotracheal tube, passes through.Although need will be larger instrument insert through described airway, still do not use other the glottis device of junction had except 15mm duroplasts or metal connector in airway device.

Utilize another potential complication of glottis airway and endotracheal tube to be, due to the pressure effect of the inflation of the arm band in pharyngeal airway device, some nerve (that is, nervus sublingualis and recurrent laryngeal nerve) is caused to damage.Recently, had been noted that the pressure damage be subject on the tip of the tongue from larger bite-block (bite-block).Different from other airway devices, the preforming under described sealant of the side in the chamber of described SLIPA device has impression, and described impression can partly prevent the nerve injury of particular point effectively.Yet the sealing station of described SLIPA device is positioned at the bottom of tongue, and not around throat.With sealing device at the bottom of tongue (base-of-the-tongue-sealing device), compare, all glottis sealing devices at approaching ring larynx regional seal of above describing (, laryngeal mask and distortion thereof, comprise the i-gel airway) all there is the risk of exerting pressure to the hyoid bone tip, described hyoid bone distance between two tips nervus sublingualis is very near, sometimes there will be a kind of nerve injury of important kind at this place.This is because necessary ring larynx seal area and weak area are overlapping.Exist the other reasons of potential injury to be herein, contrary with sealing device at the bottom of tongue, ring larynx sealing member (perilaryngeal sealer) is towards the front indent with sealing station overlapping with weakness zone.For example, i-gel is described to " mirror image of described throat entrance ".Mirror image be for by juxtaposed matching structure (with the projection of projection coupling and with the impression of impression coupling) mode reach sealing, and compare the tissue around described complementary structure may more meet/be obedient to complementary structure more suitably.

The artificial airway that provides a kind of shape suitable is provided one object of the present invention, this airway will reach dynamic self-excitation sealing (self-energizing seal) in ring larynx zone (peri-laryngeal region), and this dynamic self-excitation sealing is contrary with the constant voltage sealing reached by sealing gasket.In the positive airway pressure process, in the breathing cycle, the pressure in airway changes.This means that, in each breathing cycle, pharyngeal size all changes, and when pressure raises (, when gas is overflowed from airway) and the size increase.The design of current ring larynx glottis airway sealing device has sealing member, the seal comprises the air that is filled with scheduled volume in the seal arm band that makes the laryngeal mask pipe, perhaps in the embodiment of i-gel, make to be filled with in the seal arm band of laryngeal mask pipe the machine of soft and flexible solid (glue) the arm carrying material of predetermined.Do not design at present dynamic self-excitation sealing ring throat, and this has limited operable the blowing pressure.A purpose is to utilize the airway sealing mechanism with the automated manner response to change airway size and airway pressure, so that leakage is minimized, and prevent from following fixedly pharyngeal ischemia injury and the pressure damage of the sealing gasket device of constant volume (especially under the environment of high sealing pressure).

Another purpose is to realize than the possible higher sealing load of sealing load so far in glottis airway.In the present invention, the self-excitation sealing will provide the method that reaches this purpose.

Another purpose is to design a kind of airway, and this airway will be and the throat of different patients' different size, and make a size to match with wider patient.Due to large number quipments, all inconvenience is mobile, thus this for institute before the environment of rescue recovery extremely important.

Another object of the present invention be to provide a kind of around pharyngeal sealing without cushion device, make and can produce the relevant variable dynamic seal (packing) of anatomical shape variation that changes to airway pressure and therefore follow, to avoid by the latent lesion that constant pressure was caused on the weakness zone in throat, this latent lesion can follow the sealing mechanism that occupies larger space to produce, described pressure can be applied to the patient the hyoid bone tip nerve (, nervus sublingualis), near, cause neurological obstacle or discomfort or pain.As if ring larynx sealing device exist near the weakness zone hyoid bone tip and be positioned at the risk that the partial laryngeal nervus recurrens of introitus oesophagi is at random exerted pressure.Therefore, advantageously, utilize sealing mechanism to realize being applied to the changeable pressure of weak sealing station, this pressure changes with airway pressure.By this method, can avoid inflatable arm band or the continuous sealing load of the spongy padded coaming of solid on weakness zone, thus will with the risk minimization of pressure correlation.

Another object of the present invention is to provide a kind of anatomical shape, and with the hermetically-sealed construction of attempting providing contrary with encircling the larynx anatomical shape ground that compares, described anatomical shape is for encircling the image shape of larynx anatomical shape.

Another object of the present invention is to avoid to use above the weak area of pharyngeal front the constant pressure sealing gasket.With the sealing that realizes that ring larynx water-tight equipment is located at farther and rear (rear), help avoid the pressure of nervus sublingualis top fragile in ring larynx zone and the nerve injury of front (the place ahead) section.

Another purpose is to utilize the whole airway device of a kind of material manufacture, and this whole airway device comprises the movable initiatively connector of breathing equipment.Its purpose is that issuable disengagement is to improve the cost minimization that will assemble different parts in safety when limiting the bonding failure of the parts of being made by different materials.Therefore this make and reduced a cost that uses equipment, also improved the minimized safety of infection risk.

Another purpose is to provide a kind of airway, this airway has larger entrance, and to be connected with aeration equipment, thereby the permission instrument (for example, standard-sized endotracheal tube and armoring pipe (armoured tube)) easily pass through, make described device more generally for more occasions.

Also have another purpose to be, a kind of airway is provided, this airway utilizes three kinds of known mechanisms sucking the risk minimization of the secretions of gastric composition and accumulation in lung.For preventing that three kinds of known mechanisms that suck from comprising: the inlet seal that (a) with the form of some the obstruction mechanisms used at most of glottis airway, will enter described esophagus, (b) be that Endo-esophageal gas or liquid carrying are for the effusion path, the form of drainage tube has only been described at present, (c) provide liquid is stoped to the device in described device, the most effective mode of this device of description is the SLIPA airway.For by maximum effect, there is no to use the sealing gasket mechanism that occupies a large amount of space/volume.Current device utilizes in said mechanism, and two sometimes, but device has not been used above-mentioned three mechanisms.

Another purpose is to make stomach tube pass through to protect the airway sealing characteristics in device that mouth or nasal airways pass providing.At present, do not have the glottis airway device to be designed to the blindmate path (blind passage) that allows stomach tube to pass through nasal passage.

Another purpose is to provide a kind of dead space minimum, the anti-device of stinging, and this device can be arranged on described airway device or with airway device and be connected, so that described device is more suitable for spontaneous ventilation.

Last purpose is the risk minimization by the pressure damage of the structure in thoracic cavity infection in the penetrant that sees through described endotracheal tube arm band leaks the hospital caused or the larynx wall that utilizes endotracheal tube to cause by the design endotracheal tube, described endotracheal tube is designed to not folding, to allow large quantity of fluid at sealing surfaces seepage flow, perhaps be designed to control one or more folding sizes, make the size of described endotracheal tube will significantly make the infiltration capacity of secretions minimize, and reduce perfusion pressure damage (perfusion pressure damage) simultaneously, this perfusion pressure is inferior to high sealing pressing.

Summary of the invention

According to an aspect of the present invention, provide a kind of airway device, this airway device comprises distal part and nearly section, and this distal part and nearly section are communicated with hermetically;

Described distal part is limited with the opening far away for being connected with breathing apparatus, and this opening far away is communicated with the rod seal ground of hollow; With

Described nearly section comprises the annular seal space of hollow, the annular seal space of this hollow is limited with nearly opening, described annular seal space has the parts of the mucosal wall sealing for seal and abut against this body cavity in the mucosal wall of body cavity, and described body cavity is corresponding with described nearly opening, to be communicated with lung;

Wherein, the sealing member of described annular seal space comprises: folding longitudinally, and the cross sectional dimensions of this folding described body cavity that can Adaptive change; With described annular seal space, by elastomeric material, made, and described annular seal space has thicker and flexible relatively poor wall and thinner and flexible relative wall preferably, described thicker wall forms the framework that supports described thinner wall.

The described thinner wall of described annular seal space can be enough thin, the elasticity and the flex capability that expand or shrink corresponding to the pressure lifting in described annular seal space with the cross sectional dimensions with the described annular seal space of permission, contact with the wall sealing of described body cavity with the wall that keeps described annular seal space.

The shape and size of described annular seal space can closely be engaged in described body cavity, and described thicker wall can be enough thick, to guarantee to maintain the shape of described annular seal space when inserting in described body cavity by described airway device, to occupy the space of described body cavity, and keep described thinner wall to be resisted against on the mucosal wall of described body cavity and suspend, thereby effectively realize the self-excitation sealing.

In the embodiment of the endotracheal tube version of described device, described annular seal space is designed to be assemblied in trachea, or in the embodiment of the glottis airway version of described device, described annular seal space according to identical principle design for be assemblied in pharyngeal in.

Described body cavity can be for pharyngeal, and describedly longitudinal foldingly can comprise raceway groove, this raceway groove is at the rear (back of the body of described annular seal space, dorsal part) on face, the length direction along the sealing chamber longitudinally extends, make described annular seal space there is roughly half moon-shaped cross-sectional profiles, on the back of described cross section, there is concavity.

Described annular seal space can be for resiliency compressible, to reduce the lateral dimension in sealing chamber, described compression is subject to the effect of the sidewall of described body cavity (pharyngeal), compress described annular seal space, with the antetheca that reduces described chamber and the radius of curvature of rear wall, and therefore make the antetheca of described annular seal space and rear wall more approaching.

The antetheca of described annular seal space can have the free edge of flexible thin, and this free edge is positioned at the periphery of described nearly opening, to strengthen self-excitation, seals and realize variable wiper seal.

Described annular seal space can form blind bag at the near-end (front end/toe point) in sealing chamber, make the flexibility of the wall of described annular seal space allow described near-end to increase and expand with the pressure in described sealing bag, to strengthen described self-excitation sealing, and prevent that toe point that air passes described chamber from overflowing and enter described esophagus.

Described annular seal space can comprise the thin antetheca of the flexibility that is positioned at sealing chamber (tail) far away end, this thin antetheca is suspended between the connector of the antetheca of described annular seal space and described annular seal space and described bar by thicker wall, described thin antetheca is configured to seal against the wall of described body cavity the front of described annular seal space, overflow and enter in mouth through the sealing of ring larynx to prevent that fluid in airway device from " making progress " under the effect of pressure, and enter atmosphere subsequently.

The design of described annular seal space (shape) inside has dynamic epiglottis elevator mechanism (epiglottic elevator mechanism), comprise that the heavy wall pipe that is positioned near described bar (at the far-end in described chamber or the bar in described chamber-abutment, chamber) is used for the thin-walled of the flexibility of annular seal space, this thin-walled has free edge, wherein in the bottom of tongue, produces sealing.In use, and the tongue that the rectangular heavy wall of gas flow path embeds between tongue bottom and epiglottis can be swallowed in pleat, and along the place ahead and a distant place, the position between the inner chamber at front surface and bar-abutment, chamber moves freely thinner wall section, thereby by the self-excitation sealing mechanism, epiglottis is promoted from the normal gas channel of expiratory phase.

The shape of described annular seal space (towards front) in front can be protruded, and during use, the position of this protrusion is corresponding to the position of hyoid bone, with better with the form fit of hyoid bone, similarly, being shaped as of hyoid bone protruded previously.

The thin-walled of described annular seal space around the nearly opening of described annular seal space front can have shown in enough large horizontal (perpendicular to the axis of described annular seal space) sizes of face far away of nearly opening, position with the tip with described hyoid bone is corresponding, make in use, the free edge of described nearly opening is adjacent with the tip of described hyoid bone, therefore guarantees maximum degree of freedom and the minimum pressure that is applied to weak anatomical location.

While inserting described airway device between through patient's mouth and tooth, when lower jaw open limited in one's ability, the hollow nature of described annular seal space and compressibility can allow described annular seal space along front and back (A-P) direction depression.

The outer outstanding size that the thin-walled of the flexibility of the far-end of described annular seal space can have limited front surface or be supported by heavy wall, described heavy wall is transverse to the axis of described annular seal space, when inserting (insertion) described airway device, bend outwards allowing, and mobile restricted tongue during insertion easily.

The raceway groove that the shape of the hard thicker wall in chamber has indent, the raceway groove of this indent arrives front end from whole (vertically) length in the described chamber of tail end extend through in described chamber, therefore, when using airway device, center line between the rear pharyngeal mucous membrane (P) at the sealing back of annular seal space and seal side and rear produces space, to allow any fluid (gas or liquid) that may enter upper esophagus preferentially to overflow, and allow the effusion through the passage (thering is relatively large hole) of space and mouth or gastroscope.In addition, for the layout of the endotracheal tube with the arm band is provided with the rear portion raceway groove, trachea arm band can be arranged in described raceway groove, and inflation is to move forward whole chamber, to guarantee at very large pharyngeal excellent sealing.

The elastic construction of described rear wall raceway groove can allow to insert and guide drainage tube, and this drainage tube can enter esophagus through nasal passage or through mouth, and described drainage tube can be entered in described pharyngeal cavity by described channels direct, and enters described esophagus stomach function regulating at this pharyngeal cavity place.

The shape of cross section of described distal part bar can be the general triangle on rear top with fillet, described triangle is formed by the thick antetheca that forms described triangle base, the thin rear wall that forms the solid wall of described leg-of-mutton side and form the top of described leg-of-mutton described fillet, the shape of the cross section of described bar allows direct injection mo(u)lding, and allow described bar preferably less along depression, or the less direction bending of risk of inner chamber kink.

According to another aspect of the present invention, provide a kind of airway device, this airway device comprises distal part and nearly section, and this distal part and nearly section are communicated with hermetically;

Described nearly section comprises the parts that form annular seal space, and described annular seal space is communicated with described bar fluid, and has the parts that sealed on the mucosal wall of the pharynx that is resisted against the patient, and described nearly section defines nearly opening, to communicate with described patient's lung;

Wherein, the sealing member of described annular seal space comprises: the blind bag that is positioned at the near-end of described annular seal space, and the flexibility of the wall of described annular seal space allows described near-end to expand along with the increase of pressure in described blind bag, described blind bag can be suitable for the cross sectional dimensions of the described nearly opening of variation; With described annular seal space, by elastomeric material, made, and described annular seal space has thicker and flexible relatively poor wall and thinner and flexible relative wall preferably, described thicker wall forms the framework that supports described thinner wall.

Term " chamber " is interpreted as in this article, the space of base closed, and can broadly be explained, therefore, its explanation comprises the space of hollow fully, and by the parts of airway device completely or partially around-may supplement with patient's health the described space of sealing.Embodiment shown in the present is included in the chamber that the space by base closed of the nearly section of described airway device forms, but the present invention is not limited to this structure.

Described annular seal space can comprise flexible thin antetheca, this antetheca is positioned at the far-end of described annular seal space, and by the thicker wall of described annular seal space be suspended at described annular seal space antetheca and and the junction of described bar between, described thin antetheca is configured to be resisted against the front of the described annular seal space of sealing on the wall of described body cavity.

Described airway device can comprise at least one tubular conduit, and this tubular conduit arrives the near-end of described annular seal space from the far-end of described distal part through described bar and described annular seal space, to allow liquid removal or to enter esophagus or gastric through gastroscope.Described airway device can comprise two described tubular conduits, each described tubular conduit is longitudinally extended along described bar and described annular seal space, the near-end of described annular seal space has nearly opening, described tubular conduit interval is enough large, pass the inner chamber of described bar with the passage that allows endotracheal tube, and through the chamber between described tubular conduit.

Described bar is bent into consistent to the curved shape of patient's pharyngeal cavity with the oral cavity from the patient by crooked rigid insert, described insert can be arranged in the inner chamber of described bar with holding.The cross-sectional profiles of described insert can be U-shaped; a face that makes described inner chamber is flexible (open surface of U-shaped preferably in the back/back side); this uses together with allowing to utilize crooked photoconduction core and be combined with the bite-block functional device, and above-mentioned two functions are usually mutually exclusive.The chamber end of described insert (chamber end) has forming ends, and this forming ends has lip, and this lip protrudes to prevent to prevent from blocking if kink occurs herein.

Alternatively, described equipment can be manufactured to the bar with intrinsic curvature, so that insert redundancy (insert redundant).The triangular-section that the cross section of described bar is fillet, when this allows bar self easily crooked, inner chamber has lessly because of the crooked depression produced, utilizes the flexible insertion that do not need with some advantages relevant to described device.

Described airway device can comprise the suction protection mechanism by means of the shape in the chamber of the hollow of this airway device and structure, described suction protection mechanism provides good storage and limits the ability of described luminal sectetion thing, thereby the secretions that will accumulate or reflux enters the risk minimization of air duct.

Described airway device can comprise an independent part device of being made by a kind of flexibility and elastic material, and described airway device comprises the airway conduit with connector, this connector is positioned at described opening part far away to be connected with described breathing equipment; Described connector comprises the interior female fitting that nominal diameter is 21-22mm, and the outside frictional fit of protruding the joint for respiratory device of taper with the 22mm with standard is fixed.

The large diameter circular hole that nominal diameter in indent connector far away is 21-22mm make can the Application standard size endotracheal tube and the photoconduction core instrument of other rigid curved, with the connection by wide with there is the bar of flexible rear wall and the front near opening in pharyngeal seal member or chamber enters bronchial tree.

Can adopt identical self-excitation sealing mechanism in the endotracheal tube design, by axial connecting part, the length direction along sealed wall starts to be held in place from the middle part thick-walled pipe the thin sealed wall in described chamber, keep described sealed wall with the mucosal wall against trachea, and, the most important thing is, prevent that thin sealed wall is laterally folded in the process of inserting.

Longitudinal folding by the molding with rolling seal part, described thin sealed wall can free wxpansion and contraction along with the change of trachea size in the breathing cycle.

Can comprise the low-angle wedge shape in the cross section of sliding edge longitudinally, this cross section has sliding edge, and this sliding edge has minimum radius of curvature (that is, " sharp edge "), with folding leakage of the capillary that may collect in endotracheal tube, minimizes.

Longitudinal folding and the slightly thick harder longitudinal sliding motion edge by one or more shaping thin walls with rolling seal part, perhaps, if adopted a plurality of longitudinal folding in described design, be preferably a plurality of edges, the change of thin sealed wall and the trans D size that causes along with the breathing cycle and free wxpansion and contraction.

The cross section of sliding edge comprises the low-angle wedge shape longitudinally, this cross section and expandable chamber are overlapping, sliding edge has minimum radius of curvature, make when sliding edge with the overlapping thin chamber wall of this sliding edge on while sliding, can effectively reduce the size of capillary folding (capillary fold), and folding leakage of the capillary that may collect minimizes in endotracheal tube.

Nearly annular seal space can be connected by the district narrowed down at lateral plane with axle, makes device can more cosily be assemblied between the less string of distortion, long-term deformation damage is minimized attempting.

The accompanying drawing explanation

In order to understand better the present invention, and show how effectively to implement the present invention, will describe the present invention by the non-limiting example of reference accompanying drawing, wherein:

Fig. 1 is the front axonometric chart according to the first embodiment of airway device of the present invention, there is no shaft-like insert in described airway device;

Fig. 2 is vertical (" crown " in medical terminology) generalized section of the airway device in Fig. 1;

The axonometric chart of the airway device in Fig. 3 Fig. 1, have crooked insert in the bar of described airway device;

Fig. 4 is the axonometric chart of the shaft-like insert of the airway device in Fig. 3;

Fig. 5 is longitudinal center's cutaway view that the airway device in Fig. 1 is in original position, the airway device that this airway device is vertical version, natural torsion when described airway device is arranged in patient's pharynx;

Fig. 6 is the turnabout view that the tail end of the airway device from Fig. 1 is observed;

Fig. 7 is the vertical direction view that the front end of the airway device from Fig. 1 is observed;

Fig. 8 is identical with Fig. 2, repeats for ease of reference;

Fig. 9 to Figure 12 is respectively airway device in Fig. 8 cutaway view along position mark IX, X, XI and XII, the position of described section is: the toe point (toe) in the chamber that Fig. 9 is described airway device, the middle part that Figure 10 is described chamber, the middle part of the bar that Figure 11 is described airway device, and Figure 12 link that is described airway device;

Figure 13 is longitudinal center's cutaway view that the airway device in Fig. 1 is in original position, in the mode of arrow, showed described device the toe point downward sealing mechanism and at the upwards sealing mechanism of tongue bottom;

The axonometric chart of the airway device in Figure 14 and Figure 15 Fig. 1, showed the constant sealing station of described airway device with shade, and showed the sealing station of thin-walled by the finger of the people in Figure 14;

Figure 16 is the cross section in the chamber of the airway device in Fig. 1;

Figure 17 is the cross section in the chamber of the airway device in Fig. 1, less when pharyngeal middle when utilizing lateral wall pressure to be pressed into, and utilizes shade to show described cross section;

Figure 18 is the combination of Figure 16 and Figure 17, so that the change of contrast shape of cross section;

Figure 19 has showed that the cross section in Figure 16 combines with the similar viewgraph of cross-section in the chamber of airway device in Fig. 1, when extruding, during through the narrow gap of tooth elements, has emphasized the distortion of the sidewall in chamber;

Figure 20 is the cross section (similar to Figure 16) in the chamber of the airway device in Fig. 1, and showed the airway device for original position, with respect to main human dissection shape (hyoid bone of lordosis recurve) in front, the sealing force with respect to perienchyma of utilizing arrow to show, and showed posterior pharyngeal wall;

Figure 21 has showed the interaction between the main human dissection shape shown in Figure 20 and ring larynx glottis airway device of the prior art, utilize arrow to show the sealing force on the surrounding tissue, described ring larynx glottis airway device is set to the mirror image (therefore relative with ring larynx hermetically-sealed construction) of human dissection shape, therefore is different from common shape;

Figure 22, for showing the schematic diagram according to endotracheal tube of the present invention, has bar and self-excitation annular seal space;

Figure 23 is the axonometric chart of the endotracheal tube in Figure 22;

Figure 24 is the cross-sectional view that the endotracheal tube in Figure 22 passes described self-excitation chamber; With

Figure 25 is the longitudinal section through the endotracheal tube in Figure 22.

Main anatomy Reference numeral in accompanying drawing

The specific embodiment

With reference to accompanying drawing, in the first glottis embodiment shown in Fig. 1 to Figure 21, usually mean with Reference numeral 10 according to airway device of the present invention, and, in the second glottis embodiment of Figure 22 to Figure 25, usually mean with Reference numeral 80 according to airway device of the present invention.

Referring to figs. 1 through Figure 21, airway device 10 comprises airway, and this airway is divided into the two parts with two openings: the nearly section 20 and the distal part 12 with opening 14 far away that have respectively nearly opening 22.Nearly section 20 comprises annular seal space, the sealing chamber has for sealing in the mucosal wall of the body cavity the patient with against the parts that seal on the patient's body lumen mucosal wall, and patient's body cavity is corresponding with described nearly opening, to be communicated with lung, and distal part 12 comprises the parts that are connected with breathing apparatus.Annular seal space 20 has longitudinal folding, this longitudinal folding cross section that can change described body cavity, described longitudinal foldingly made by elastomeric material, and there is different wall thickness, perhaps more specifically, have the heavy wall pipe thin-walled,

heavy wall

30,26 provides the framework of hard (flexibility is less), with the more flexible

elastic wall section

24,25 that supports in this way described chamber, with the thin-walled of guaranteeing described chamber, with the mucosal wall of described body cavity, seals and contacts.

The thin-walled 24,25 in chamber 20 is enough thin, to allow chamber 20 to there is elasticity and flex capability, this elasticity and flex capability allow described chamber 20 can for example, when airway pressure raises or is reduced to lower pressure (, ambient pressure), expand as patient's air flue chamber size and shrink the same self-excitation sealing of expanding or shrinking-therefore obtaining described intracavity.

Wherein relevant body cavity is pharyngeal, and the longitudinal folding raceway groove (gutter) 32 that comprises, the whole length of these raceway groove 32 extend through annular seal spaces 20, and be positioned at the back side or the back in described chamber, therefore obtain cross section for roughly back or the back side indent in ，Gai chamber, half moon-shaped chamber.

The design in chamber 20 is suitable for being assemblied in pharyngeal cavity (pharyngeal cavity), and the shape in described chamber approaches the circle wedge shape, this circle wedge shape has near-end (or front end) and the wider narrow end that far-end (or tail end)-described near-end (or front end) is the circle wedge shape, and be known as toe point (toe) 28, the bar of distal part 12 (stem) 16 is connected with described far-end (or tail end).The thinner wall section in chamber 20 and heavy section be respectively, and described thinner wall section is positioned at the place ahead and the front portion of sidewall 24, and heavy section is positioned at the rear portion of rear wall 30 and sidewall 26, and sidewall 26 has generally flat front surface, and this front surface has large nearly (or front) opening 22.Open front 22 is enough large, with around throat, and corresponding with the throat opening, before the thin-walled side and the opening on front surface 24 there is sufficient neighboring area to allow front dynamic seal (packing) or the self-excitation sealing around larynx.The shape of the thickness sufficient to guarantee of thicker wall 26,30 holding chamber 20 when inserting airway device 10, to occupy pharyngeal cavity (pharyngeal space), and keep the surface of the thin-walled in the place ahead (front side) to be suspended on pharynx wall, so that the self-excitation sealing effectively.

The flexibility of antetheca 24 makes self-excitation sealing (obtaining different wiper seal) become possibility, and antetheca 24 strengthens by free edge 23, and free edge is around the periphery in the front hole 22 in chamber 20.

Self-excitation sealing utilizes the size of the toe point 28 in chamber 20 to raise and expands to prevent that air from passing in the front end in chamber 20 or sharp 28 blind bags that form of toe (blind pouch) overflows and enter in esophagus with pressure.

Shown in Fig. 5 and Figure 13, annular seal space 20 comprises the diverticulum of esophagus by antetheca 24 " downwards " sealing, and antetheca 24 can be suitable for changing the cross sectional dimensions of the entrance of esophagus.

By thin movably antetheca 24 be positioned at the tail end in chamber 20 or the thin movably wall 25 of distal face is realized the self-excitation sealing mechanism, thin removable wall 25 is suspended between the connector of described antetheca and bar 16 by thicker wall 26, sealing effectively in front, prevent under the effect of the pressure of gas in airway device 10 by ring larynx sealing " make progress " effusion, and enter in mouth, enter subsequently atmosphere.Bag (base-of-tongue pouch) (seeing Fig. 5 and Figure 13) at the bottom of this tongue that can be described as being formed by wall 25, at the bottom of this tongue, bag for " making progress " sealing in mouth.

(adjacent front wall 24 as shown in Figure 5 at its near-end (front end/toe point) for annular seal space 20, the position of the black arrow in left side in two black arrows in Figure 13) form blind bag, make the flexibility of the wall of described annular seal space allow described near-end to increase and expand with described sealing bag internal pressure, strengthen the self-excitation sealing, go forward side by side in esophagus to prevent that toe point that gas passes described chamber from overflowing.

Annular seal space 20 can comprise flexible thin antetheca 25, this thin antetheca 25 is positioned at (tail) far away end of described annular seal space, this thin antetheca 25 is shown in Fig. 5 and Figure 13 by the thicker wall 26(of annular seal space 20) be suspended at the antetheca of annular seal space 20 and the connector of the annular seal space that is connected with described bar between, described thin antetheca 25 is configured to lean against the front in the described chamber of sealing on the wall of described body cavity, to prevent that fluid from sealing " making progress " by the ring larynx and overflow and enter in mouth under the effect of the pressure of airway device, enter subsequently atmosphere.

The design in chamber 20 (shape) inside has dynamic epiglottis elevator mechanism (epiglottic elevator mechanism) and comprises the face far away of chamber wall 26 or bar-chamber junction point and very thin-walled and flexible part 25, described face far away or bar-chamber joint face is the thickest near the junction point near bar 16 and chamber 20; thin-walled and flex region 25 have free edge 23, wherein in the bottom of tongue, produces sealing.In use, at bar 16 and the heavy wall 26 at the junction point place in chamber 20, be orientated transverse to the longitudinal air flow passage through chamber 20, and the tongue that heavy wall 26 embeds between tongue bottom and epiglottis can be swallowed in pleat (glosso-epiglottic fold), yet; along the place ahead and a distant place, the position between the inner chamber 17 of front surface 24 and bar-chamber joint moves freely thinner wall section 25, thereby by the self-excitation sealing mechanism, epiglottis is promoted from the normal gas channel of expiratory phase.

Rounded shapes due to chamber 20, so the size in chamber 20 is more suitable for the sizes that the patient dissects, wherein indent is (backward for antetheca 24 and

rear wall

30,32, protrude forward), therefore, the cross section of airway device 10 can for the approximate circle angle or, for approximate crescent, the radius of curvature of this half moon-shaped rear wall 30 be less than the combination average radius of the front of antetheca 24 and described sidewall.The planform in chamber 20 is that cross section is fillet, basic is crescent structure, this half moon-shaped structure has recess feature, can increase the curvature of described crescent from the compression stress of patient's pharyngeal sidewall, therefore reduce front radius and the rear radius of curve, and make described front surface and rear surface nearer, and make the whole lateral dimension in described chamber less.On the contrary, airway pressure raises and can exert pressure to 20 medial wall, chamber 21, and this will tend to increase the radius of antetheca and rear wall-therefore the increase closure size in described chamber.

The shape of cross section in chamber 20 is lordosis (towards lordosis), during use, will with the shape with hyoid bone, better mate corresponding to the level height (as shown in figure 20) of hyoid bone (HB), and the shape of described hyoid bone is also protruded forward.

The face far away of the large opening 22 in the tenuity 24 of 20 front, chamber can be enough wide (transverse to the size of the axis in chamber), the height that opening 22 is identical at the tip with hyoid bone with throat is corresponding, makes the tip of the contiguous hyoid bones of free edge 23 of throat's opening 22-therefore guarantee flexibility and will be applied to the pressure minimum of fragile anatomical position.

Due to the chamber 20 of hollow be flexible, hollow with half moon-shaped, in the time of between the chamber by hollow is inserted through mouth and tooth, and, when lower jaw opens (as Figure 19) limited in one's ability, the structure of flexible cavity 20 permission front facing backwards caves in effectively.

The outer outstanding size of the thin-walled flexible seals 25 of limited front surface or the far-end that is arranged in chamber 20 that supported by rear wall parts 26 allows to bend outwards (as shown in the arrow of Figure 13), and the tongue of mobile restricted system at an easy rate during insertion, described thin-walled flexible seals 25 is substantially transverse to the axis in described chamber.

The raceway groove 32 that the shape of the hard thicker wall 30 in chamber 20 has indent, the raceway groove of this indent arrives front end from whole (vertically) length in the described chamber of tail end extend through in described chamber, therefore, when using airway device 10, center line between the rear pharyngeal mucous membrane P at the sealing back of annular seal space and seal

side

32,30,26 and rear produces space 33(as shown in figure 20), to allow any fluid (gas or liquid) that may enter upper esophagus preferably to overflow, and allow the effusion through the passage (thering is relatively large hole) of space 33 and mouth or gastroscope.

The elastic construction of rear wall raceway groove 32 allows insert drainage tube and drainage tube is guided to esophagus and gastric, drainage tube can be through nasal passage or through mouth, and can be by the pharyngeal cavity 33 between the

outer wall

32,30 of raceway groove 32 introduction chambers 20 and posterior pharyngeal wall P (as shown in figure 20), and enter from here esophagus.

The shape of cross section of distal part bar 16 is roughly triangle, this triangle has the top of the fillet at rear, the thick antetheca 19a of distal part bar 16 forms leg-of-mutton flat, and the entity triangle sidewall 19c of distal part bar 16 and thin rear wall 19b form top (as shown in figure 11), preferably less along depression with the airway that allows direct injection mo(u)lding, or the less direction bending of risk of inner chamber 17 kinks.

The leading edge of one or more tubular conduits 40 from connector 42 to described chamber can be arranged or refer to that 28 through

bar

18,16 and chamber 20, to allow overflow or to allow stomach tube through entering esophagogastric probability.

Length direction along bar 12 and chamber 20 is provided with two parallel passage 40(as shown in Fig. 3 and Fig. 8), passage 40 has the nearly opening of the

front end

28,44 that enters chamber 20, has sufficient distance between parallel passage and allows endotracheal tube through passing through between bar inner chamber 17, described chamber and parallel passage 40.

Rigidity plastics insert 35(by the bending in the airway lumen 17 that is arranged on described bar is as shown in Figure 4), the shape of bar 16 is crooked (as shown in Figure 3), consistent with the pharyngeal cavity shape with approximate right angle.

Airway device 10 can be crooked plastic insertion piece 35(as shown in Figure 1, Figure 2 with shown in Fig. 8).Due to some advantages of flexibility with do not need to airway device 10 space that insert 35 is relevant, so the triangular cross section of the fillet of bar 16 (as shown in figure 11) steady arm 16 self is easily crooked, and the depression of inner chamber 17 than normal when crooked the depression of generation few.

The shape of cross section of crooked hard plastic insertion piece 35 is U-shaped (or " passage " shape), and a face that makes airway lumen 17 is flexible (open surface 36 of U preferably in the wings/back).This allows crooked photoconduction core to use in conjunction with insert 35 together with airway device 10, and insert 35 is as bite-block.Before the present invention, the use of bite-block and crooked photoconduction core are usually mutually exclusive.The chamber end of described insert has forming ends, and this forming ends has the lip 37 in Fig. 4, and this lip 37 protrudes to prevent to prevent from blocking if kink occurs herein.

By the ability of the secretions in storage preferably and restricted room is provided, the hollow design in chamber 20, as effectively sucking protection mechanism (aspiration protection mechanism), enters the risk minimization of air duct with the secretions that will accumulate or reflux.

Except optional insert 35, this airway device 10 can also be manufactured to the single part device of being made by the material of same flexibility and scalable (elasticity), this airway device 10 comprises airway, and this airway has the connecting device be connected with breathing apparatus.Opening 14 far away is at connector far away 42 places of the distal part 18 of bar 12, this opening far away comprises the interior female fitting that nominal diameter is 21-22mm, with the Outboard Sections frictional fit of the breathing connector joint (breathing attachment connector) of the outer male conical of the 22mm with standard, is connected.

The large diameter circular hole that nominal diameter in the opening far away 14 of indent connector 42 far away is 21-22mm make can the Application standard size endotracheal tube and the photoconduction core instrument of other rigid curved, enter bronchial tree with the front near opening (anterior proximal opening) 22 by opening 14 and bar 16 and inner chamber 17 and pharyngeal seal member or chamber 20.

One of sealing mechanism of the present invention is distinctive is characterised in that longitudinal folding mechanism, and this longitudinal folding mechanism provides the constant pressure sealing away from the weak forefoot area near ring larynx zone.At present, all glottises (SG) ring larynx sealing airway except the Baska airway with dynamic " front organ folds (anterior concertina fold) " all has fixing constant pressure sealing gasket, the sealing pad in the sealing of ring larynx (for example can be divided into, laryngeal mask and i-gel airway) or tongue base area sealing (for example, Combitube, Copa airway, trunnion conduit, SLIPA airway).Yet airway device 10 has fixing constant pressure sealing between the different self-excitation dynamic seal (packing) mechanism in next-door neighbour's ring larynx zone above the front surface of the shadow region 27 shown in Figure 14 and Figure 15 and sidewall 24 and front.Constant pressure ring larynx pad in other rings larynx sealing members (PL), for example laryngeal mask or i-gel airway (as shown in the C in Figure 21), comprise the rubber cushion of inflatable packer or i-gel airway, all is positioned at around the next-door neighbour's glottis sealed or near the larynx opening.Sealing mechanism of the present invention is dual, this dual finger constant pressure pad sealing station 27 and due to the trend of launching half moon-shaped chamber 20 in described airway device dynamically or self-excitation, and apply the sealing of reinforcement on front surface and more flexible surface 24,25.Adjacent loops larynx zone, dynamic seal (packing) position in the present invention, and when airway pressure will be installed 10 expansion, the dynamic seal (packing) position can be for whole pharyngeal.Yet, constant pressure sealing station 27 can be known as ring larynx zone, although not with ring larynx zone next-door neighbour, but, away from front (the place ahead) some weak anatomical structure, contrary constant pressure sealing station 27 is positioned at the back zone of sidewall 26 and size the widest part of rear wall 30.

In order to prevent from causing the secretions seepage of thoracic cavity infection in hospital, endotracheal tube design with self-excitation sealing is described below with reference to Figure 22 to Figure 25, the airway tracheal catheter device (airway tracheal tube device) 80 of being made by a kind of flexible material has been showed in this endotracheal tube design, this airway tracheal catheter device 80 comprises the airway conduit that is divided into two

parts

82,86, and this airway conduit has two

open ends

81,92.

A part of airway tracheal catheter device 80 is chamber 86, this chamber 86 has thin sealed wall 90, this thin sealed wall 90 can be started to be held in place from middle part thick-walled pipe 88 by the length direction along sealed wall 90 by axial connecting part 99, to keep the mucosal wall of described sealed wall against trachea, and, the most important thing is, prevent that thin sealed wall is laterally folded in the process of inserting.

Longitudinal folding by the molding with rolling seal part (rolling seal) 100, thin sealed wall 90 and free wxpansion and contraction along with the change of trachea size in the breathing cycle.

Comprise the low-angle wedge shape on the cross section of the sliding edge longitudinally 96 of airway tracheal catheter device 80, this cross section and expandable chamber 90 are overlapping.(the edge 98 of sliding edge 96 has minimum radius of curvature, " sharp edge "), make when sliding edge 96 with the overlapping thin chamber wall 90 of this sliding edge on while sliding, can effectively reduce the size of capillary folding (capillary fold), and folding leakage of the capillary that will usually collect minimizes in endotracheal tube.

In Figure 24 to Figure 27, the parts that following numeral in accompanying drawing early will be identical by the function of the numeral in bracket replace: 14(81), 22(92), 12(82), 20(86,90), 24& 25(90), 30& 26(88), comprise 24,26,30 the contiguous vertical inner groovy 32(100 of roughly half moon-shaped cross section).According to identical principle, in the embodiment of conduit trachea airway device 80, annular seal space 86 is designed to be assemblied in trachea, and in the embodiment of glottis airway device 10, annular seal space 20 be designed to be assemblied in pharyngeal in.

By one or more shaping thin wall longitudinal folding 100 and slightly thick slightly hard longitudinal sliding motion edges 96 with rolling seal part, perhaps, if adopted a plurality of longitudinal folding in described design, be preferably two or more edges, the change of thin sealed wall 90 and the trans D size that causes along with the breathing cycle and free wxpansion and contraction.

In Figure 23 and Figure 24, nearly annular seal space 86 can be connected by the zone 84 narrowed down at lateral plane with axle 82, makes device 80 can more cosily be assemblied between the less string of distortion, long-term deformation damage is minimized attempting.

Claims

1. an airway device (10), this airway device (10) comprises distal part (12) and nearly section (20), this distal part (12) and closely section (20) be communicated with hermetically;

Described distal part (12) is limited with the opening far away (14) for being connected with breathing apparatus, and this opening far away (14) is communicated with hermetically with the bar (16) of hollow; With

Described nearly section comprises the annular seal space (20) of hollow, the annular seal space of this hollow (20) is limited with nearly opening (22), described annular seal space (20) has for sealing in the mucosal wall of body cavity with against the parts of the mucosal wall of this body cavity sealing, described body cavity is corresponding with described nearly opening, to be communicated with lung;

It is characterized in that, the sealing member of described annular seal space (20) comprising: folding (32) longitudinally, this folding cross sectional dimensions that can adapt to the variation of described body cavity; And described annular seal space (20) is made by elastomeric material, and described annular seal space (20) has thicker and flexible relatively poor wall (26,30) with thinner and flexible relative wall preferably (24,25), described thicker wall (26,30) form to support the framework of described thinner wall (24,25).

2. airway device according to claim 1 (10), it is characterized in that, the described thinner wall (24 of described annular seal space (20), 25) enough thin, to have, the cross sectional dimensions that allows described annular seal space (20) expands corresponding to the pressure in described annular seal space (20) changes or elasticity and the flex capability of contraction, with the wall that keeps described annular seal space (20), with the wall of described body cavity, contacts hermetically.

3. airway device according to claim 1 and 2 (10), it is characterized in that, the shape and size of described annular seal space (20) closely are engaged in described body cavity, and described thicker wall (26,30) enough thick, to guarantee when inserting in described body cavity by described airway device (10), maintain the shape of described annular seal space (20), to occupy the space of described body cavity, and keep described thinner wall (24,25) be resisted against on the mucosal wall of described body cavity and suspend, thereby effectively realize the self-excitation sealing.

4. airway device according to claim 3 (10), it is characterized in that, described body cavity is pharyngeal, and the described longitudinal folding raceway groove (32) that comprises, this raceway groove (32) longitudinally extends along the length direction of sealing chamber (20) on the back of described annular seal space (20), make described annular seal space there is roughly half moon-shaped cross-sectional profiles, there is concavity (33) on the back of described cross section.

5. airway device according to claim 4 (10), it is characterized in that, described annular seal space (20) is resiliency compressible, to reduce the lateral dimension in sealing chamber (20), described compression is subject to the effect of the sidewall of described body cavity, compress described annular seal space (20), with the antetheca that reduces described chamber (20) and the radius of curvature of rear wall, and therefore make antetheca and the rear wall of described annular seal space (20) more approaching.

6. according to the described airway device of claim 4 or 5 (10), it is characterized in that, the antetheca of described annular seal space (20) has the free edge (23) of flexible thin, and this free edge (23) is positioned at the periphery of described nearly opening (22).

7. according to the described airway device of any one in claim 4 to 6 (10), it is characterized in that, described annular seal space (20) forms blind bag at the near-end (28) of sealing chamber (20), makes the flexibility of the wall of described annular seal space (20) allow described near-end (28) to increase and expand with the pressure in described sealing bag.

8. according to the described airway device of any one in claim 4 to 7 (10), it is characterized in that, described annular seal space (20) comprises the thin antetheca (25) of the flexibility that is positioned at sealing chamber (20) far-end, this thin antetheca (25) is suspended between the connector of the antetheca of described annular seal space (20) and described annular seal space (20) and described bar (16) by thicker wall, and described thin antetheca (25) is configured to seal against the wall of described body cavity the front of described annular seal space (20).

9. according to the described airway device of any one in claim 4 to 8 (10), it is characterized in that, described annular seal space (20) comprises dynamic epiglottis elevator mechanism, this dynamic epiglottis elevator mechanism comprises the wall (26) of described annular seal space (20) and the wall (25) of described annular seal space (20), described wall (26) is near described bar (16) and thicker, described wall (25) is thinner and have a flexibility, described wall (25) has free edge (23), and the sealing of tongue bottom occurs in described free edge (23) and locates.

10. according to the described airway device of any one in claim 4 to 9 (10), it is characterized in that, the front of the shape of described annular seal space (20) is protruding, and in use, described high spot is corresponding to the position of hyoid bone (HB).

11. according to the described airway device of any one in claim 4 to 10 (10), it is characterized in that, described nearly opening (22) is enough large at the face far away place of this nearly opening (22) lateral dimension, corresponding with the tip location with described hyoid bone, in use, make the described free edge (23) of described nearly opening (22) adjacent with the tip of described hyoid bone.

12. according to the described airway device of any one in claim 4 to 11 (10), it is characterized in that, when between the mouth through the patient and tooth, inserting described airway device (10), cave in along fore-and-aft direction in the hollow nature of described annular seal space (20) and resiliency compressible permission sealing chamber (20).

13. according to the described airway device of any one in claim 4 to 12 (10), it is characterized in that, the thin-walled (25) of described flexibility that is positioned at the far-end of described annular seal space (20) has limited front surface size, this front surface is supported by the described heavy wall (26) of the axis transverse to described annular seal space, to allow outwardly-bent and mobile restricted tongue easily in inserting described airway device (10) process.

14. according to the described airway device of any one in claim 4 to 13 (10), it is characterized in that, described annular seal space (20) has elasticity, relatively thick rear wall (30), this rear wall (30) be shaped as indent, to limit described raceway groove (32), make while using and produce pharyngeal cavity (33) at the described raceway groove (32) be arranged between described rear wall (30) and described pharyngeal mucous membrane (P), this pharyngeal cavity (33) can be used in fluid and overflows and/or tool passage.

15. airway device according to claim 14 (10), it is characterized in that, the elastic construction of described rear wall raceway groove (32) allows insert and guide drainage tube to enter esophagus, described raceway groove (32) guides to described drainage tube in described pharyngeal cavity (33), and enters the entrance of described esophagus from described pharyngeal cavity (33).

16. according to the described airway device of any one in claim 4 to 15 (10), it is characterized in that, the shape of cross section of described distal part bar (16) is generally the general triangle on the rear top with fillet, described triangle is by the thick antetheca (19a) that forms described triangle base, the thin rear wall (19b) that forms the solid wall (19c) of described leg-of-mutton side and form the top of described leg-of-mutton described fillet forms, the shape of the cross section of described bar (16) allows the described bar of direct injection mo(u)lding (16), and allow described bar (16) less or less direction bending of kink risk along depression.

17. an airway device (10), this airway device comprises distal part (12) and nearly section (20), and this distal part (12) and nearly section (20) are communicated with hermetically;

Described nearly section comprises the parts that form annular seal space (20), described annular seal space (20) is communicated with bar (16) fluid of described hollow, and there are the parts that sealed on the mucosal wall of the pharynx that is resisted against the patient, and described nearly section is limited with nearly opening (22), to communicate with described patient's lung;

It is characterized in that, the sealing member of described annular seal space (20) comprising: the blind bag that is positioned at the near-end (28) of described annular seal space (20), and the flexibility of the wall (24) of described annular seal space (20) allows described near-end (28) to expand along with the increase of pressure in described blind bag, described blind bag allows to be suitable for the cross sectional dimensions that described nearly opening (22) changes; Described annular seal space (20) is made by elastomeric material, and described annular seal space (20) has thicker and flexible relatively poor wall (26,30) and thinner and flexible relative wall preferably (24,25), described thicker wall (26,30) forms the framework that supports described thinner wall (24,25).

18. airway device according to claim 17, it is characterized in that, described annular seal space (20) comprises the thin antetheca (25) of the flexibility of the far-end that is positioned at described annular seal space (25), the thicker wall of this thin antetheca (25) by described annular seal space (20) is suspended between the connector of the antetheca of described annular seal space (20) and described annular seal space (20) and described bar (16), and described thin antetheca (25) is configured to seal against the wall of described body cavity the front of described annular seal space (20).

19. according to the described airway device of above-mentioned any one claim (10), it is characterized in that, described airway device comprises at least one tubular conduit (40), and this tubular conduit (40) arrives the near-end (28) of described annular seal space (20) from the far-end of described distal part (12) through described bar (16) and described annular seal space (20).

20. airway device according to claim 19 (10), it is characterized in that, described airway device comprises two described tubular conduits (40), each described tubular conduit (40) is longitudinally extended along described bar (16) and described annular seal space (20), the near-end (28) of described annular seal space (20) has nearly opening, described tubular conduit (40) interval is enough large, pass the inner chamber (17) of described bar (16) with the passage that allows endotracheal tube, and through the chamber (20) between described tubular conduit (40).

21. according to the described airway device of above-mentioned any one claim (10), it is characterized in that, described bar (16) is bent into consistent to the curved shape of patient's pharyngeal cavity with the oral cavity from the patient by crooked rigid insert (35), described insert (35) can be arranged in the inner chamber (17) of described bar (16) with holding.

22. airway device according to claim 21 (10), is characterized in that, the cross-sectional profiles of described insert (35) is U-shaped, and it is flexible making a face of described inner chamber (17).

23. according to the described airway device of above-mentioned any one claim (10), it is characterized in that, described airway device comprises that, by means of the shape of the chamber of the hollow of this airway device (20) and the suction protection mechanism of structure, described suction protection mechanism provides good storage and limits the ability of described luminal sectetion thing.

24. according to the described airway device of above-mentioned any one claim (10), it is characterized in that, described airway device (10) comprises an independent part device of being made by a kind of flexibility and elastic material, and described airway device comprises connector (42), this connector (42) is positioned at described opening far away (14) to be located, to be connected with described breathing equipment; Described connector (42) comprises the interior female fitting that nominal diameter is 21-22mm, and the outside frictional fit of protruding the joint for respiratory device of taper with the 22mm with standard is fixed.

25. according to the described airway device of any one in claims 1 to 3 (80), it is characterized in that, by axial connecting part (99), the length direction along described sealed wall (90) is held in place from middle part thick-walled pipe (88) the described thin sealed wall (90) of described chamber (86).

26. airway device according to claim 25, is characterized in that, longitudinal folding by having at least one of rolling seal part (100), the sealed wall of described thin-walled (90) is along with the size of trachea in the breathing cycle changes and freely expands and shrink.

27. airway device according to claim 26 (80), it is characterized in that, described vertical rolling seal part comprises sliding edge narrow, wedge shape (96), and the radius of curvature that this sliding edge (96) is located at the edge (98) of this sliding edge (96) is little.

28. according to the described airway device of claim 26 or 27 (80), this airway device (80) comprises a plurality of the described longitudinal folding of rolling seal part (100) that have, it is characterized in that, there is rolling seal part (100) and longitudinal sliding motion edge (98) that at least one is thick by least one, in the described breathing cycle that causes lateral dimension to change, described thin sealed wall (90) free wxpansion or contraction along with this trachea change in size.

29. according to the described airway device of any one in claim 25 to 28 (80), it is characterized in that, described near annular seal space (86) and axle (82) are connected by the zone (84) that is positioned at lateral plane and narrows down.